The background you need to know is that donepezil (brand name, Aricept, manufactured by Eisai and marketed by Pfizer) is one of several drugs intended to slow the progress of Alzheimer's disease, but that have never been shown to work very well. In research studies, the drugs will improve thinking, memory, or function by a few points on some measuring scale, but typically the patient or family cannot detect any real improvement. People feel obliged to use these drugs anyway since Alzheimer's is such a bad disease and we have nothing better to offer.

OK, so it's 2010, and Aricept, previously made in 5 and 20 milligram doses, is about to go off patent, and sales will be lost to the generic makers. How to evergreen this drug? Eisai apparently took a page from Abbott Labs' experience with fenofibrate:http://brodyhooked.blogspot.com/2012/04/yet-another-evergreening-ploy-more-on_10.html
As we've discussed here and in HOOKED, the more usual evergreening process (extending the patent life of a drug to keep profits rolling in) has involved going into the chemistry lab to tweak the drug molecule in some minor way, then claiming that one has discovered a new miracle breakthrough drug. But why bother even to go into the lab if you can con the regulators to allow you simply to make a new dosage form of the drug, then claim that it's a brand new drug and deserves patent protection?

So Eisai went to the FDA with a new, 23-milligram form of Aricept with studies purporting to show that it was safe and effective. The FDA's own staff, as Schwartz and Woloshin tell the tale, said this was garbage--the study failed to show that the new dose was any more effective than the old 10 mg dose in global disease improvement. (There was a statistically significant, but clinically tiny improvement in cognitive function.) The staff also noted that when you upped the dose, guess what, patients suffered a lot more side effects--and side effects in the frail elderly can be nothing to sniff at. The chiefs of that section of the FDA overruled the staff and approved the "new" drug.

Eisai-Pfizer then launch a huge ad campaign aimed at both the general public and at docs. The campaign for the public transmitted the message that if you don't beg your doctor to prescribe this new wonder drug for Grandma, then obviously you don't love her. The ad for docs blatantly misrepresented the study data and claimed that the new dose form had been shown to be superior on global measures to the old one--and soft-pedaled the evidence for worse side effects.

When various do-gooders pointed out this lie, the FDA looked into it and discovered that they could not legally fault the company for the ads, because the ads contained the same information as was in the official FDA-approved product label. Apparently when the company sent in the proposed text for the new label, the FDA goofed and approved the incorrect language, despite their own in-house evidence that the labelling was false. Eventually the FDA fixed both the label and the ad campaign--only 18 months and 68,000 prescriptions after the ad campaign started.

In short, if this one instance is any clue, it's business as usual at the FDA, and it doesn't seem to matter who's in the White House.

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